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Cardiac Transplant DisorderNCT02670408

Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation

An observational study of Cardiac Transplant Disorder, run by University of Alberta at 13 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Demonstrate the impact of the Molecular Microscope Diagnostic System as the standard of care for heart transplant patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Transplant Disorder
What is being tested?
Endomyocardial biopsy
Type of treatment
Surgery or procedure
How many people
900 participants
Where
13 sitesin 8 countries
Study dates
Jan 2016to Jul 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study aims to recruit 1200 biopsies from heart transplant patients for clinical indications and the standard of care biopsies.

Who may be able to join

  • biopsy for clinical indications

Who cannot join

  • no consent
  • pregnant women

Trial locations and contacts

13 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Konrad S Famulski, PhD contact

1 7804921725

konrad@ualberta.ca

Robert Polakowski, PhD contact

1780 492 5091

polakows@ualberta.ca

13 sites in 8 countries

United States5 sites

  • Annette C. and Harold C. Simmons Transplant Institute, BaylorScott&White Research Institute

    Dallas, Texas, 75246

    Completed

  • UCLA Medical Centre

    Los Angeles, California, 90024

    Completed

  • Cedars-Sinai Heart Institute

    Los Angeles, California, 90048

    Completed

  • Virginia Commonwealth University, Division of Cardiology

    Richmond, Virginia, 23298

    Completed

  • Cardiovascular Medicine, University of Utah Health

    Salt Lake City, Utah, 84132

    Completed

Other trials in United States

Canada2 sites, 1 recruiting

  • Alberta Transplant Applied Genomics Center, University of Alberta

    Edmonton, Alberta, T6G 2E1

    Konrad Famulski, PhD, 7804921725, konrad@ualberta.ca

    Philip F Halloran, MD PhD

    Recruiting

  • Division of Cardiology, University of Alberta

    Edmonton, Alberta, T6G 2R7

    Completed

Other trials in Canada

Australia1 site, 1 recruiting

  • Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute

    Darlinghurst, NSW 2010

    Carmen Herrera, MD, 61-02-8382-3025, peter.macdonal@svha.org.au

    Peter MacDonald, MD

    Recruiting

Other trials in Australia

Austria1 site, 1 recruiting

  • Department of Cardiac Surgery, Medical University of Vienna

    Vienna, A-1090

    Arezu Aliabadi, MD, 43-1-40400-5643, arezu.aliabadi@meduniwien.ac.at

    MD

    Recruiting

Other trials in Austria

Czechia1 site, 1 recruiting

  • Institute for Clinical and Experimental Medicine - IKEM

    Prague, 14021

    Tereza Novakowa, novt@ikem.cz

    Vojtech Melenovsky, MD, PhD

    Recruiting

Other trials in Czechia

France1 site

  • Service de Néphrologie-Dialyse Adultes , Hôpital Necker-Enfants Malades

    Paris, 75015

    Completed

Other trials in France

Italy1 site

  • Heart Failure and Heart Transplant Unit, University of Bologna

    Bologna, 40138

    Completed

Other trials in Italy

Spain1 site

  • Advanced Heart Failure Transplant Unit

    A Coruña

    Completed

Other trials in Spain

About this study

Official title: Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation, a Multicenter Study (INTERHEART)

Demonstrate the impact of the Molecular Microscope Diagnostic System as the standard of care for heart transplant patients.

Read the detailed description

The current standard for biopsy-based diagnoses of rejection of heart transplants is the ISHLT classification from 2004, which represents a widely-used international consensus, based on morphological criteria of the cellular infiltrate within the myocardial specimen system with certainties and some arbitrary and blurred parameters. Recent data-driven approaches using molecular and conventional technologies indicate that this system produces incorrect diagnoses with potential harm to patients due to inappropriate treatment. To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC, University of Alberta) has developed a new diagnostic system - the Molecular Microscope® Diagnostic System (MMDx) that interprets biopsies in terms of their molecular phenotype, and combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. The MMDx developed first in kidney transplant biopsies because phenotypes are well established, will now be adapted to heart transplant endomyocardial biopsies (EMBs). The present study will develop a Reference Set of EMB, adapt the MMDx system to assess and report EMBs; and validate and refine this system in 900 unselected prospectively collected for clinical indications and a standard of care EMBs from North American and European Centers. In addition to demonstrating the real-time feasibility and potential value of this System in patient care, the study will develop and optimize a transparent and user-friendly reporting format to communicate this information to clinicians and obtain detailed feedback to improve its utility. We refine now our MMDx system using a new type of analysis (see primary outcome) and the resulting MMDx report. Currently, INTERHEART recruited 1912 biopsies from 1279 patients.

Being tested
Endomyocardial biopsy
Keywords
Heart transplant, global gene expression, molecular diagnostics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endomyocardial biopsyProcedure or surgery

    One of several endomyocardial biopsy bites taken as the standard of care. We are asking now for two endomyocardial biopsy bites, to determine tissue sampling variability.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assign molecular scores (probability) of T cell mediated rejection, antibody mediated rejection in heart transplant biopsies, in a reference set of 200 biopsies

    Create a molecular classifier that predicts antibody mediated and T cell mediated rejection, based on the archetypal analysis.

    Measured: 2 years

Secondary outcomes (1)

  1. Assign in real time (three working days upon biopsy receipt) molecular scores (probability) of T cell mediated rejection and antibody mediated rejection.

    The molecular phenotype of a newly acquired sample predicts the histologic and clinical features of this sample when compared to the reference set.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2027 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02670408
Sponsor's protocol ID
ATAGC 002
Status last verified
Jun 2026
First submitted
22 Jan 2016
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Madill-Thomsen KS, Halloran PF. Precision diagnostics in transplanted organs using microarray-assessed gene expression: concepts and technical methods of the Molecular Microscope(R) Diagnostic System (MMDx). Clin Sci (Lond). 2024 Jun 5;138(11):663-685. doi: 10.1042/CS20220530.

    PubMed 38819301

  • Loupy A, Duong Van Huyen JP, Hidalgo L, Reeve J, Racape M, Aubert O, Venner JM, Falmuski K, Bories MC, Beuscart T, Guillemain R, Francois A, Pattier S, Toquet C, Gay A, Rouvier P, Varnous S, Leprince P, Empana JP, Lefaucheur C, Bruneval P, Jouven X, Halloran PF. Gene Expression Profiling for the Identification and Classification of Antibody-Mediated Heart Rejection. Circulation. 2017 Mar 7;135(10):917-935. doi: 10.1161/CIRCULATIONAHA.116.022907. Epub 2017 Feb 1.

    PubMed 28148598

  • Halloran PF, Potena L, Van Huyen JD, Bruneval P, Leone O, Kim DH, Jouven X, Reeve J, Loupy A. Building a tissue-based molecular diagnostic system in heart transplant rejection: The heart Molecular Microscope Diagnostic (MMDx) System. J Heart Lung Transplant. 2017 Nov;36(11):1192-1200. doi: 10.1016/j.healun.2017.05.029. Epub 2017 May 29.

    PubMed 28662985

  • Halloran PF, Reeve J, Aliabadi AZ, Cadeiras M, Crespo-Leiro MG, Deng M, Depasquale EC, Goekler J, Jouven X, Kim DH, Kobashigawa J, Loupy A, Macdonald P, Potena L, Zuckermann A, Parkes MD. Exploring the cardiac response to injury in heart transplant biopsies. JCI Insight. 2018 Oct 18;3(20):e123674. doi: 10.1172/jci.insight.123674.

    PubMed 30333303

  • Parkes MD, Aliabadi AZ, Cadeiras M, Crespo-Leiro MG, Deng M, Depasquale EC, Goekler J, Kim DH, Kobashigawa J, Loupy A, Macdonald P, Potena L, Zuckermann A, Halloran PF. An integrated molecular diagnostic report for heart transplant biopsies using an ensemble of diagnostic algorithms. J Heart Lung Transplant. 2019 Jun;38(6):636-646. doi: 10.1016/j.healun.2019.01.1318. Epub 2019 Feb 6.

    PubMed 30795962

  • Halloran PF, Madill-Thomsen KS. The Molecular Microscope Diagnostic System: Assessment of Rejection and Injury in Heart Transplant Biopsies. Transplantation. 2023 Jan 1;107(1):27-44. doi: 10.1097/TP.0000000000004323. Epub 2022 Dec 8.

    PubMed 36508644

  • Halloran PF, Madill-Thomsen K, Mackova M, Aliabadi-Zuckermann AZ, Cadeiras M, Crespo-Leiro MG, Depasquale EC, Deng M, Gokler J, Hall SA, Kim DH, Kobashigawa J, Macdonald P, Potena L, Shah K, Stehlik J, Zuckermann A, Reeve J. Molecular states associated with dysfunction and graft loss in heart transplants. J Heart Lung Transplant. 2024 Mar;43(3):508-518. doi: 10.1016/j.healun.2023.11.013. Epub 2023 Nov 30.

    PubMed 38042442

  • Halloran PF, Madill-Thomsen K, Aliabadi-Zuckermann AZ, Cadeiras M, Crespo-Leiro MG, Depasquale EC, Deng M, Gokler J, Kim DH, Kobashigawa J, Macdonald P, Potena L, Shah K, Stehlik J, Zuckermann A. Many heart transplant biopsies currently diagnosed as no rejection have mild molecular antibody-mediated rejection-related changes. J Heart Lung Transplant. 2022 Mar;41(3):334-344. doi: 10.1016/j.healun.2021.08.004. Epub 2021 Aug 26.

    PubMed 34548198

  • Halloran PF, Madill-Thomsen K, Aliabadi-Zuckermann AZ, Cadeiras M, Crespo-Leiro MG, Depasquale EC, Deng M, Gokler J, Hall S, Jamil A, Kim DH, Kobashigawa J, Macdonald P, Melenovsky V, Patel J, Potena L, Shah K, Stehlik J, Zuckermann A. Redefining the molecular rejection states in 3230 heart transplant biopsies: Relationships to parenchymal injury and graft survival. Am J Transplant. 2024 Aug;24(8):1414-1426. doi: 10.1016/j.ajt.2024.03.031. Epub 2024 Mar 26.

    PubMed 38527588

  • Gauthier PT, Gerhardt LM, Jahn L, Hinze C, Halloran PF. Digital cytometry of leukocyte landscapes reveals shared correlates of rejection across organ transplants. J Clin Invest. 2026 Sep 22:e208686. doi: 10.1172/JCI208686. Online ahead of print.

    PubMed 42771484

  • Madill-Thomsen KS, Reeve J, Aliabadi-Zuckermann A, Cadeiras M, Crespo-Leiro MG, Depasquale EC, Deng M, Goekler J, Kim DH, Kobashigawa J, Macdonald P, Potena L, Shah K, Stehlik J, Zuckermann A, Halloran PF. Assessing the Relationship Between Molecular Rejection and Parenchymal Injury in Heart Transplant Biopsies. Transplantation. 2022 Nov 1;106(11):2205-2216. doi: 10.1097/TP.0000000000004231. Epub 2022 Oct 21.

    PubMed 35968995

  • Halloran PF. Integrating molecular and histologic interpretation of transplant biopsies. Clin Transplant. 2021 Apr;35(4):e14244. doi: 10.1111/ctr.14244. Epub 2021 Feb 17. No abstract available.

    PubMed 33595110

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Transplant Disorder, run by University of Alberta at 13 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Canada, Australia, Austria, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Konrad S Famulski, PhD (1 7804921725, konrad@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assign molecular scores (probability) of T cell mediated rejection, antibody mediated rejection in heart transplant biopsies, in a reference set of 200 biopsies (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02670408, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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